An interventional study of Whole-Body Vibration Intervention and Exercise Intervention Group in Flexible Flatfoot, sponsored by Nanfang Hospital, Southern Medical University. Recruiting at 1 site in China. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-03.
Sponsored by Nanfang Hospital, Southern Medical University · Not applicable, Interventional, and Treatment
This clinical study was a prospective intervention study. The growth and development parameters and kinematic parameters of 120 children were planned to be collected for an observational study, and then the sensors were used to collect long-term gait data for 4 weeks and record the occurrence of foot pain. Children were assigned to the observation group, exercises intervention group, or WBV vertical rhythm intervention group according to their wishes. After 4 weeks of intervention, the dynamic and static foot posture differences between the intervention group and the observation group were analyzed and compared.
This clinical study plan to recruit 120 subjects aged 6-18 years to collect the following parameters:
A wearable sensor is used to collect gait data for more than 8 hours per day for 4 weeks, and all enrolled children wear the wearable sensor in their daily lives. The obtained data is uploaded to the cloud server through the mobile application, and the data is uploaded through the APP to achieve remote monitoring and daily event recording. When the subject has a foot pain event, it should be reported to the researchers through the APP in time. After determining the foot pain based on the VAS score, the foot pain subjects will be divided into the observation group, the exercise intervention group and the WBV vertical rhythm intervention group according to their willingness.
The children in the observation group followed the doctor's advice to rest and did not participate in sports activities. The children in the intervention group were followed up by the researchers to implement the WBV vertical rhythm or exercise training program. The follow-up time was once a week and the training lasted for 4 weeks. The self-developed APP was used for researchers to remotely monitor and guide children's training movements and track training progress. The device uses a Huawei S-TAG anklet that matches HarmonyOS 2+/Android 6.0+/iOS 9.0+. IP68 (GB/T 4208-2017), waterproof grade 50 meters; Bluetooth: BT 5.0 to transmit data; Running scenario battery life: running 1 hour a day, running 5 days a week, stationary placement when not in use, battery life of 30 days.
173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.
This study's planned enrollment of 120 is above the median of 40 across 122 interventional studies indexed under Flatfoot.
Browse Flatfoot studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 490 studies on the registry; 214 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Enrolled children will be trained at home using a vertical rhythm device under the guidance of researchers and parental supervision. WBV training lasted for four weeks, five days a week, 15 minutes a day, each movement lasted for 30 seconds, and 30 seconds of rest between groups.
Procedure: Exercise Intervention Group
Children were instructed to rest and not participate in physical activity
The enrolled children will be supervised by their parents and follow the teaching of the self-developed APP for Yi Jin Jing exercises. The training lasts for 4 weeks, 5 days a week, 15 minutes a day, 12 movements in total, each movement is 1 minute, and the rest between groups is 15 seconds.
Procedure: Whole-Body Vibration Intervention
Whole-Body Vibration Intervention
Traditional Chinese medical exercises training
Static foot posture
Static foot posture is evaluated using 3D morphometric scanner, X-ray, and Foot Posture Index-6
Time frame: Baseline , pre-intervention and immediately after the intervention
Motional foot posture
Motional foot posture is evaluated using Passive optical motion capture, and wearable sensors
Time frame: Baseline , pre-intervention and immediately after the intervention
Foot pain events
Visual Analogue Scale (VAS) is used to evaluate foot pain, which asks patients to rate their pain level on a scale of 0 to 10 (0 = no pain; 10 = "worst pain ever"). On the VAS scale, patients draw a hash mark representing their pain level on an unmarked 10-cm line, with the left side marked as "no pain" and the right side marked as "unbearable pain".
Time frame: Baseline , pre-intervention
Bone maturity
Bone age taken by dual energy X ray bone age instrument, the equipment radiation is extremely low, the equivalent of flying two minutes, or about 20 minutes of walking in the sunshine, won't cause harm to human body. Bone mineral density (BMD) was measured by ultrasound bone densitometer, which can be used to measure the BMD of calcaneus in children without radiation and trauma.
Time frame: Baseline , pre-intervention
PDFs hosted by the registry, ClinicalTrials.gov.
Started Jan 2024 (actual). Primary completion is estimated for Dec 2027, 47 months after the start.
Of 89 non-industry interventional studies with no phase under Flatfoot, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 15. This study's planned 47 months is above that.
Counting every sponsor, half of 89 studies reached it within 7 months; a quarter within 2 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
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Nanfang Hospital, Southern Medical University →